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# Info Collection Extension on CLIA Device Categorization
- URL: https://www.fdaweb.com/info-collection-extension-on-clia-device-categorization/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144412

*Federal Register* notice: FDA is seeking comments on an information collection extension related to a guidance on “Administrative Procedures for Clinical Laboratory Improvement Amendments (CLIA) Categorization — 42 CFR 493.17 (OMB Control Number 0910-0607)." The guidance describes procedures FDA uses to assign the complexity category to a device, which affects what type of CLIA certificate a laboratory obtains. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-13561.pdf?ref=fdaweb.com).